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OpenTrials
Completed

NCT Number: NCT01464151

Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study

Both ulcerative colitis and Crohn's colitis are associated with an increased risk of developing colorectal cancer (CRC). Although the increased risk of CRC in colitis patients is well established, several studies show that the risk varies widely between patients, depending on the presence of risk factors. Recently, several of these risk factors were implemented in the updated British guidelines for surveillance which are now used to determine surveillance intervals in our center. The new guideline recommends stratification of patients in a high, medium or low risk group depending on the presence of clinical and endoscopic risk factors and to adjust the surveillance interval accordingly. Although these guidelines provide a first step towards an individualized surveillance regimen, current data regarding risk factors for IBD (inflammatory bowel disease) -associated CRC are solely based on retrospective studies. Prospective data on the phenotype and genotype reliably predicting the risk of CRC is needed to further optimize surveillance in the future.

Objectives:

1. To confirm established and identify new predictive factors for colorectal cancer in a prospective cohort of IBD patients undergoing regular surveillance. Dysplasia or colorectal cancer will be the primary outcome. 2. To provide evidence that mucosal healing results in a significant reduction of colorectal dysplasia/neoplasia in IBD patients and that this is associated with 5-ASA (5-aminosalicylic acid) or anti-TNF (tumor necrosis factor) maintenance therapy. 3. Study the expression of several tumor markers in biopsies, blood and faeces at baseline and determine whether expression of these markers can predict dysplasia or colorectal cancer development during follow-up.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AMC, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of ulcerative colitis, crohn's colitis or indeterminate colitis
  • Disease duration ≥ 8 years
  • Inflammation of at least 30% of colonic mucosa at some point between IBD diagnosis and inclusion
  • Age 18 - 70 years
  • Signed informed consent

Exclusion criteria

  • High grade dysplasia or colorectal cancer before inclusion
  • subtotal or total colectomy before inclusion
  • Clotting disorder or use of anticoagulants that can not be temporarily discontinued
  • Serious comorbidities which prevent performing a colonoscopy
  • Limited life expectancy
  • Clinical or endoscopical disease activity (at the discretion of the treating physician)

Treatment and study plan

Primary outcomes

  1. low- or high grade dysplasia or colorectal cancer during follow-up

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Ferring Pharmaceuticals
  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2011
Primary completion
2021
Study completion
2021
First posted
Nov 3, 2011
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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